Migraine, chronic migraine, chronic pain
Conditions
Interventions
Transcranial direct current stimulation is used in the 2 mA current for 20 minutes with anopic pole in the left dorsolateral prefrontal region and cathode pole in the right supraorbital region, with t
Device
Other
E02.331.750
F02.463.551
Sponsors
Universidade Federal da Paraíba
Universidade Federal da Paraíba
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients of both sexes, aged 18-65 years, who have been diagnosed clinically as having chronic migraine, according to the third edition of the Classification of the International Headache Society (ICHD-3) will be selected. Only patients who will be able to continue treatment in the twelve sessions during the four consecutive weeks pre-programmed will be accepted, although up to three alternating or two justified faults are tolerated, and these should be reset on the following business day, in order to minimize the dropouts and promote adherence to treatment. Flexible hours will be offered to receive the therapy, as well as direct contact, through telephone contact with the participants, confirming the evaluation dates and reinforcing adherence to the treatment.
Exclusion criteria
Exclusion criteria: Exclusion criteria include the presence of headache attributed to some other neurological pathology or associated neuropsychiatry, the use of drugs modulating central nervous system (CNS) activity, presence of metallic implants located in the head, and patients with pacemakers cardiac.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As a primary outcome, the association of transcranial direct current stimulation with mindfulness practice is expected to promote the reduction of disability in performing daily life activities (ability to perform household chores, to have a healthy social life, to go to work without missing ...) of the chronic migraine patients for acting in the prophylaxis painful new episodes of migraine. For this evaluation, the MIDAS questionnaire (Mental incapacity assessment) will be applied before and after the 12 intervention sessions in both active and placebo groups. The aim is to evaluate the inability to perform daily and professional tasks in patients with migraine. Such an instrument contains five questions that must be met with the number of days that the patient has failed to perform the specified activity because they are currently having a migraine episode, which is a useful tool to identify the severity of the migraine. This questionnaire was validated in the Portuguese language and can be applied in people with educational level and different social origins, because it is considered easy to be answered (FRAGOSO, 2002). We will use this questionnaire at the beginning and end of the treatment to evaluate if there is improvement in the symptoms of chronic migraine. The results will be analyzed through the software program SPSS (Statistical Package for Social Sciences) version 25.0, where parametric or non-parametric analyzes will be performed, depending on the normality of the data, and a level of significance will be considered p <0.005. We expect the results of the primary outcome to be considered significant (p <0.05). | — |
Secondary
| Measure | Time frame |
|---|---|
| As one of the secondary outcomes, it is expected to find an improvement in the evaluation of the impact of headache on the daily life of chronic migraine patients. For this, the HIT-6 questionnaire (headache impact test) will be used. HIT-6 is a validated questionnaire in our highly reliable language that assesses the frequency of headache impact on the quality of life of patients with chronic and episodic migraine and, moreover, discriminates the types of migraine that the patient presents (episodic, chronic or non-migraine). This questionnaire presents six evaluation questions of these parameters through the options: never, rarely, sometimes, very often and always. For each of these frequencies is associated a predetermined value that will be added at the end to arrive at the score equivalent to the impact of the headache (for example: rarely 8 points and always worth 13 points). This score will be compared before and after all intervention sessions have been completed in both the active and placebo groups in order to assess whether or not there has been a decrease in the frequency of headache impact on participants' quality of life. The results of the questionnaire will be analyzed through the software program SPSS (Statistical Package for Social Sciences) version 25.0, where parametric or non-parametric analyzes will be performed, depending on the normality of the data, and a level of significance will be considered p <0.005. We expect the results to be considered significant (P <0.05).;As another secondary outcome, it is expected to find an increase in the level of mindfulness of these patients before and after the twelve sessions of the associated intervention of transcranial stimulation by direct current to the practice of mindfulness. For this, the FFMQ-BR questionnaire (questionnaire of the five facets of mindfulness) will be used. The FFMQ-BR is a mindfulness assessment tool that was validated in Brazil in 2014. This questionnaire is subdivided into fi | — |
Countries
Brazil
Contacts
Public ContactLuana Pimenta
Universidade Federal da Paraíba
Outcome results
None listed